Advanced Training in Biological Evaluation of Medical Devices

This course provides you with in-depth knowledge to be able to perform a biological evaluation according to ISO 10993-1 and a toxicological risk assessment according to ISO 10993-17. It is intended for already experienced professionals wishing to gain further insight into the subject. For an introduction to the field, please see our basic biocompatibility course.

You will learn how to plan and conduct a biological evaluation within a risk management process, also over the whole life cycle of the device. With the recently completed revision of ISO 10993-1:2025 and the revisions of the subparts -18:2020 and -17:2023, more emphasis is today put on material characterization and a risk-based approach where novel testing should be justified. In addition, EU MDR also sets higher demands on substances contained in and released from devices. The course will give you a solid understanding of the chemical characterization process and toxicological risk assessment framework. It includes practical exercises on how to interpret supplier information, how to determine required sensitivity in chemical tests (AET), and on how to perform toxicological risk assessments. The course also discusses important aspects when testing cannot be avoided, as well as strategies to reduce the amount of animal tests. The trainer has extensive experience of in vitro testing and will share her knowledge on available in vitro tests and how to include such data in a risk-based approach to biological safety evaluation.

The course content is illustrated with our own experiences from testing and evaluation of medical devices for biocompatibility, as well as experiences from interactions with notified bodies and other authorities.

After this course you will be prepared for independently carrying out a biological evaluation, with increased knowledge about the requirements on biological safety that your finished product will need to fulfill, and practical experience of how to do this evaluation and document it for review by authorities. You will also get familiar with the tools to be used to perform the assessment within a risk management process, especially how to do calculations for toxicological risk assessments. Gap analysis of existing documentation to novel standard versions, in particular ISO 10993-1:2025, is also covered.

Course content

• Short recap of how to do biocompatibility evaluations in a risk-based manner
• Chemical characterization – theoretical and practical
  –  Get the most out of supplier information
  –  How to design extractables studies in accordance with ISO 10993-18
• Toxicological risk assessments according to ISO 10993-17:2023. Get familiar with the standard and learn to use it
  – Practical exercises
• Strategies for minimizing the need for animal tests
• ”Common pitfalls” – avoid the typical mistakes in your biological risk assessment
• Sample preparation – how may your choices in sampling and test design affect results?
• How to handle changes in device and standard updates
  Experience from working with CROs, designing in vitro and in vivo testing strategies and performing supplier audits
• What is required for biological evaluation in different jurisdictions? (EU MDR, US FDA, etc.)
• Case studies and interactive workshops throughout the day

Who should attend

Everyone with prior knowledge on biocompatibility assessment who needs a deeper understanding of the biological evaluation requirements, e.g. professionals with responsibility for biocompatibility assessments, or professionals working with design and development, project management, regulatory affairs or quality assurance.

Previous knowledge level

Prior experience of biocompatibility assessments and working knowledge of the ISO 10993 series is expected for participants in this course.
If you are new to the field of biocompatibility, please consider instead to take our basic/intermediate biocompatibility course.

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